“Sometimes the best way to inform policy is not to offer a solution but rather to highlight the problem”

UNICEF – Office of Research

Background

The majority of studies on the risks and benefits of medication use during pregnancy suffer from various limitations, including small sample sizes, lack of statistical power, or have sub-optimal study designs to investigate rare outcomes such as congenital malformations, low birth weight or prematurity. To circumvent these limitations, large national administrative databases or registries have been increasingly used in the field of perinatal pharmacoepidemiology, recognizing the importance of large size longitudinal pregnancy cohorts. Large longitudinal cohort studies often allow for the understanding of health trends, as well as predisposing or protective factors for illness or injury. The generated knowledge can thereby provide solid grounds for policy making and program interventions in the health sector with the ultimate goal to impact health at the population level. However, although large, province-wide databases often lack enough statistical power to detect low to moderate risks of rare adverse outcomes.

The Cohort aims to bring together data from various Canadian provinces to address a critical public health issue facing Canada and the rest of the world: the impact of prescription drug use during pregnancy on long-term health outcomes in the mother and child.

The multi-provincial pregnancy-birth cohorts we intend to align will be developed by linking several health care administrative databases available through the individual provinces’ ministries of health. Healthcare administrative databases have become a cornerstone in the process of assessing performance and providing feedback to improve quality of health care delivery and outcomes at a population-level. The single-payer integrated system of health care delivery in Canada has facilitated the linking of inpatient, outpatient (including emergency department visits), hospital, ambulatory care, pharmaceutical, immunization, and laboratory data in the six provinces. The volume of data generated by linking the health care databases to environment and census data has brought us into the wider realm of “big-data”. Ultimately, the individual Mother-Child cohorts will also allow for multi-provincial results replication and expedite causality assessment.

Scientific Expertise

Canada is a World leader in the field of Medications and Pregnancy/Children, and the team members are the most influential researchers in Canada as well as being among the most distinguished scientists in this field at the international level. All investigators have intrinsic knowledge of the perinatal pharmacoepidemiology field; have a strong background and understanding of administrative databases, biostatistics, meta-analytical tools/models, programming, database linkages; have great expertise in teratology, embryology; have extensively used administrative databases throughout their careers and training; and have a clear understanding of the knowledge gap and unmet needs in the field of perinatal pharmacoepidemiology.

The Canadian Mother-Child Cohort will approximately include 3.4 million pregnancies and 3 million children, resulting in one of the largest and most representative longitudinal cohort of pregnancies, mothers and children in the World.

Visit the team page for a complete list of our investigators

Participating Provinces

At its inception, the Cohort will bring together health data from six provinces, namely Quebec, Ontario, Manitoba, Saskatchewan, Alberta, and British Columbia. Data will include diagnoses, procedures, and medication use, sociodemographic indicators, hospital stay data to address a critical public health issue facing Canada and the rest of the world: the impact of prescription drug use during pregnancy on short- and long-term health outcomes of the mother and child. Crude health / sociodemographic / hospital data already collected within each province will be used to generate province-specific cohorts, which will be aggregated and combined across provinces.

Ultimately, the Cohort aims to unite cohorts from all 10 Canadian provinces.

Privacy and Confidentiality

Privacy and confidentiality will be ensured by the co-investigators within each province as well as the Cohort’s Executive Committee. This will be done by keeping all denominalized crude data as well as each Mother-Child cohort developed in a single pre-identified provincial site under the supervision and responsibility of the provincial co-investigators – on secure servers. The full cohort data will never be analyzed for a study (a minimal relevant sub-dataset will be used), and all analyses of crude data will be centralized within the provincial site. All analysts sign a confidentiality agreement form to make sure that we keep track of users.

Coordinating Centre

As the only province to have already put in place a longitudinal pregnancy/mother/child cohort with validated measures, definitions and algorithms – the Quebec Pregnancy Cohort, or QPC, model – Quebec will be host to the Cohort’s Coordinating Centre. Province-specific cohorts will use standardized algorithms to determine crucial data, which have all already been developed by the existing team in Quebec to build their QPC. While province-specific data will remain in their respective province, provincial aggregate indicators will be calculated and downloaded in a secure repository in Montreal – CHU Sainte-Justine.

The CHU Sainte-Justine is the largest mother and child centre in Canada and one of the four most important pediatric centres in North America. It is Quebec’s only health care establishment exclusively dedicated to children, adolescents and mothers in Quebec and other countries. The CHU Sainte-Justine also hosts its own Research Center, which boasts more than 200 researchers ensuring its international influence. Therefore, the Research Center of the CHU Sainte-Justine is uniquely situated to be the Cohort’s Coordinating Centre.